Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer

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Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed (adeno)carcinoma of the prostate refractory to hormone therapy

Note: Patients may also have measurable disease in the lymph nodes (retroperitoneal, pelvic or inguinal only), prostate and /or prostatic bed; measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm =< 21 days prior to registration

PSA progression defined as two consecutive increases in PSA value over the previous reference value; the first increase of PSA should occur no earlier than one (1) week after the reference measurement; all patients need to demonstrate continued PSA elevation with an increasing PSA four weeks after the required cessation of their antiandrogen treatment; the required cessation period is 4 weeks for flutamide, nilutamide, and Megace-based treatment, and 8 weeks for bicalutamide-based treatment

One of the following:

Continuing primary androgen suppression (LHRH agonist)

Orchiectomy

WBC >= 2000/mm^3

Absolute neutrophil count (ANC) >= 1500/mm^3

PLT >= 100,000/mm^3

Hgb >= 9.0 g/dL

Total bilirubin =< institutional upper normal limits (UNL)

AST =< 1.5 x UNL

Serum creatinine =< 1.5 x UNL

PSA >= 5 ng/mL

Serum testosterone < 50 ng/dL =< 3 months prior to registration

Estimated life expectancy of >= 6 months

ECOG Performance Status (PS) 0, 1, or 2

Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent

If sexually active, willing to use an accepted and effective method of contraception consistently for the duration of study participation

Psychiatric illness/social situations that would limit compliance with study requirements

HIV-positive patients receiving combination anti-retroviral therapy

Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancer from which the patient has been disease free for >= 5 years